Healthy Aging Through Dietary Intervention

Healthy Aging Through Dietary Intervention: Multiparametric Quantification of Function and Pathophysiology of the Aging Heart and Prevention of Age-associated Decline in Exercise Capacity Through Dietary Flavanols

To test the impact of flavanol supplementation of cardiac and vascular function and subsequently on exercise capacity in elderly individuals

Study Overview

• Status: Completed
• Conditions: Aging, Healthy
• Intervention / Treatment: Drug: Flavanol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Düsseldorf, NRW, Germany, 40225
      • Heinrich Heine University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• age 50-79

Exclusion Criteria:

• non-cardiac limitations of exercise capacity such as orthopedic or neurological disorders, BMI >35 kg/m2, active smoking, uncontrolled blood pressure, diabetes, COPD, atrial fibrillation, cardiomyopathy, coronary heart disease, valvular heart disease, cardiac pacemaker, acute respiratory tract infections, missing ability or missing cooperation to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; nutrient matched control capsule	Drug: Placebo; Assessement, supplementation placebo for 30 days with either Placebo or Flavanols, Re-assessment
Experimental: Flavanol; 500 mg of flavanols twice daily	Drug: Flavanol; Assessement, supplementation for 30 days with either Placebo or Flavanols, Re-assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise capacity	maximum power output during cardiopulmonary exercise testing	30 days
peakVO2	maximum oxygen uptake during cardiopulmonary exercise testing	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
flow mediated vasodilation (FMD)	marker for vascular function	30 days
Oxygen pulse	oxygen uptake per heart beat (VO2/HR) as measured during cardiopulmonary exercise testing	30 days
aortic stiffness	cardiac magnetic resonance assessment of aortic diameter, distensibility and flow	30 days
diastolic strain	cardiac magnetic resonance (CMR) based assessment of left ventricular strain	30 days
Left ventricular function	systolic ejection fraction calculated based on magnetic resonance volumetric assessment of left ventricle	30 days
left atrial volume index (LAVi)	cardiac magnetic resonance based assessment of left atrial volume index	30 days
brain natriuretic peptide (nt-proBNP)	blood chemistry, nt-proBNP measurement	30 days
aortic pulse wave velocity (PWV)	cardiac magnetic resonance based assessment of pulse wave velocity in ascending and descending aorta	30 days
diastolic strain rate (SR)	cardiac magnetic resonance (CMR) based assessment of left ventricular strain rate early and during atrial contraction	30 days

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): February 5, 2023

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: AgingEx

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No